Effectiveness of a Problem-solving Intervention for Common Adolescent Mental Health Problems in I… (NCT03630471) | Clinical Trial Compass
CompletedNot Applicable
Effectiveness of a Problem-solving Intervention for Common Adolescent Mental Health Problems in India
India250 participantsStarted 2018-08-20
Plain-language summary
We will conduct a two-arm individually randomized controlled trial in six Government-run secondary schools in New Delhi. The targeted sample is 240 adolescents in grades 9-12 with persistent, elevated mental health difficulties and associated impact. Participants will receive either a brief problem-solving intervention delivered by lay counsellors (intervention), or enhanced usual care comprised of problem-solving booklets (control). Self-reported adolescent mental health difficulties and idiographic problems will be assessed at 6 weeks (co-primary outcomes) and again at 12 weeks post-randomization. In addition, adolescent-reported impact of mental health difficulties, perceived stress, mental wellbeing and clinical remission, as well as parent-reported adolescent mental health difficulties and impact scores, will be assessed at 6 and 12 weeks post-randomization. Parallel process evaluation, including estimations of the costs of delivering the interventions, will be conducted.
Who can participate
Age range13 Years – 20 Years
SexALL
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Eligibility criteria:
For adolescent participants:
* Enrolled as a student in Grades 9-12 (corresponding to 13-20 years of age)
* Experiencing elevated mental health symptoms, based on response in the borderline or abnormal range (scores of 19 or higher for boys and 20 or higher for girls) on the self-reported SDQ Total Difficulties scale
* Experiencing significant distress and/or functional impairment, based on response in the abnormal range (scores of 2 or higher) on the self-reported SDQ Impact Supplement
* Experiencing difficulties for \>1 month, based on response to the self-reported Chronicity item from the SDQ Impact Supplement
* For adolescents under 18 years of age, able to provide informed assent to participate and supported by parental consent
* For adolescents over 18 years of age, able to provide informed consent to participate
For parent participants:
* A primary parental caregiver or guardian for the index adolescent
* Able to provide informed consent to participate, and if adolescent age 18+ years, parental involvement is supported by the index adolescent
* Proficient in spoken English or Hindi
Exclusion criteria:
For adolescent participants:
* Requiring urgent medical attention (defined as needing emergency treatment or in-patient admission)
* Unable to communicate clearly (due to a speech or hearing disability or inability to comprehend one of the program's languages)
* Already receiving intervention for mental health problems
* Received PRIDE interve…